MAUDE Adverse Event Report: COVIDIEN LLC ENDOFLIP; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number	EF-322N
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while setting up the endoflip catheter 16cm nasal tip for use during the procedure, the medtronic endoflip machine noted the catheter to be defective during the initial diagnostic analysis.The catheter was removed from the machine and a new catheter was placed.

• Brand Name: ENDOFLIP
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): COVIDIEN LLC; 3062 bunker hill lane; santa clara CA 95054
• MDR Report Key: 16014111
• Report Number: 16014111
• Device Sequence Number: 6371438
• Product Code: FFX
• UDI-Device Identifier: 10884521809413
• UDI-Public: 10884521809413
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/18/2022
• Report Date (Section F): 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: EF-322N
• Device Lot Number: 2210293JZ(20)03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 12/20/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 161 KG
• Patient Race: White
• Date Report Sent to FDA: 11/18/2022